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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K070193
Device Name ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES
Applicant
Envitec-Wismar GmbH
S65w35739 Piper Rd.
Egale,  WI  53119
Applicant Contact STEPHEN GORSKI
Correspondent
Envitec-Wismar GmbH
S65w35739 Piper Rd.
Egale,  WI  53119
Correspondent Contact STEPHEN GORSKI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/22/2007
Decision Date 05/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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